MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 02/01/2005

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: department of obstetrics and gynecology, bundang cha general hospital, pochon cha university.Initial reporter address 1: 351 yatap-dong, bundang-gu,sungnam-si, kyonggi-do, 463-712.Park, hye ri, et al."uterine restoration after repeated sloughing of fibroids or vaginal expulsion following uterine artery embolization." european radiology 15.9 (2005): 1850-1854.

Event Description

It was reported via a journal article that patient complications occurred.Abstract the aim of our study is to present our experience with uterine restoration after repeated sloughing of uterine fibroids or transvaginal expulsion following uterine artery embolization (uae) and to determine its safety and outcome.One hundred and twenty-four women (mean age, 40.3 years; age range, 29 - 52 years) with symptomatic uterine fibroids were included in this retrospective study.We performed arterial embolization with poly(vinyl alcohol) particles.Clinical symptoms and follow-up information for each patient were obtained through medical records.At an average of 3.5 months (range, 1 - 8 months) after embolization, magnetic resonance imaging examinations with t1 and t2 weighted and gadolinium - enhanced t1 weighted images were obtained for all patients.The mean follow-up duration was 120 days (90 - 240 days).Eight (6.5%) patients experienced uterine restoration after repeated sloughing of uterine fibroids or spontaneous transvaginal expulsion.The locations of the leiomyomas were submucosal (n=5), intramural (n=2) and transmural (n=1).The maximum diameter of the fibroids ranged from 3.5 to 18.0 cm, with a mean of 8.4 cm.The time interval from embolization to the uterine restoration was 7 - 150 days (mean 70.5 days).The clinical symptoms before and during vaginal sloughing or expulsion were lower abdominal pain (n=4), vaginal discharges (n=3), infection of necrotic myomas (n=2) and cramping abdominal pain (n=1).Gentle abdominal compression (n=1) and hysteroscopic assistance (n=1) were required to remove the whole fibroid.No other clinical sequelae, either early or delayed, were documented.Magnetic resonance images revealed the disappearance of leiomyomas, intracavitary rupture resulting in transformation of intramural or transmural myomas into submucosal myomas and localized uterine wall defects.Although the small size of this study precludes a strict conclusion, there appear to be few serious complications directly related to vaginal expulsion.Vaginal expulsion or fibroid sloughing is a possible course following uae that is manageable, and the patients should be informed about this possibility.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55113
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15105947
• MDR Text Key: 296613006
• Report Number: 2134265-2022-07947
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other